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OpenTrials
Active, Not Recruiting

NCT Number: NCT05373095

Rudi Kundini, Pamoja Kundini

This protocol describes an individually randomized trial that will include adult people living with HIV (PLHIV) currently receiving HIV care at one of two participating health facilities and identified as high risk for disengagement from care by a machine learning algorithm. Participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the management of HIV. For those who meet clinic eligibility criteria for enhanced adherence counseling, which at the included study sites is when client's viral load reaches a detectable level (>1000 copies/ml), this includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Intervention arm participants will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (referred to as PKC sessions).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geita Regional Referral Hospital, Geita, Tanzania

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About this study

This protocol describes a 2-armed parallel individually randomized controlled trial for which 692 PLHIV who meet eligibility criteria, are currently accessing care at a participating health facility (Katoro Health Center, Geita Town Council Hospital, Geita Regional Referral Hospital, or Nyankumbu Health Center), and have provided informed consent to be part of the study will be randomized in a 1:1 ratio (n=346 PLHIV in each arm), stratified by site, to the control or intervention group. The investigators will use machine learning to finalize a predictive model based on routinely collected medical and pharmacy record data to identify and recruit PLHIV for participation at participating facilities who are at high-risk for disengaging from HIV care.

Eligible and consenting participants randomized to the control arm will receive standard of care HIV clinical services according to Tanzania's National Guidelines for the Management of HIV. Criteria for enrollment into enhanced adherence counseling sessions includes when client's viral load reaches a detectable level (>1000 copies/ml). Enhanced adherence counseling includes the standard provision of three, once-monthly, 60-minute nurse-led individual, enhanced adherence counseling sessions, starting on the day of the result and for two months after. Counseling focuses on the meaning of viral loads and supportive, non-judgmental strategies for adherence and visit attendance. Sessions are conducted in an individual, 1:1 setting with a trained counselor who is on the clinical staff, or in a group setting with a trained counselor who is on the clinical staff. A minimum of three sessions are required. Eligible and consenting participants randomized to the intervention arm will receive the same standard HIV care services plus the offer of a cash transfer paired with visit attendance and attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first payment will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining enhanced adherence counseling sessions. Due to the nature of the intervention, participants will not be blinded to intervention assignment. The primary endpoint is viral load suppression (<1000 copies/ml) at 12 months following study enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • PLHIV on ART;
  • Age 18 years or older;
  • Phone ownership OR consistent phone access;
  • Not already enrolled in/currently attending enhanced adherence counseling sessions at the facility
  • Living in Geita Region and intends to receive care at a study facility for the next 12 months;
  • Classified as "high-risk" for loss to follow-up (LTFU) from HIV care, and
  • Provides written informed consent for participation

Treatment and study plan

PKC (adapted adherence counseling) and Conditional Cash Transfers

Behavioral

The intervention includes up to 3 cash transfers of 22,500 Tanzanian Shillings (~$10) paired with attendance at each of the three adapted enhanced adherence counseling sessions (PKC sessions). The first cash transfer will occur at enrollment; the next two cash transfers are payable upon visit attendance and attendance of the two remaining PKC sessions. The cash transfers will include extra funds for transaction fees, typically <$1.

Primary outcomes

  1. 12-Month Viral Suppression

    Time frame: 12 months

    The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 12 months after study enrollment.

Secondary outcomes

  1. 6-month retention in care

    Time frame: 6 months

    The proportion of people living with HIV (PLHIV) on ART at 6 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)

  2. 12-month retention in care

    Time frame: 12 months

    The proportion of people living with HIV (PLHIV) on ART at 12 months after study enrollment (PEPFAR considers those not retained on ART to include those who died, disengaged from care, stopped ART, or had no evidence of care for ≥28 days after a missed visit. Participants not found after exhaustive tracing efforts to rule out silent transfers will be classified as not retained on ART)

  3. 12-month durable viral load

    Time frame: 12 months

    Proportion with durable HIV viral suppression 12 months after enrollment: at least 2 viral load measurements taken from up to 6 months prior to study enrollment and up to and including 12 months following study enrollment and all are undetectable (<1000 copies/ml) will have met criteria for durable viral suppression at 12 months.

  4. 12-month Appointment Attendance

    Time frame: 12 months

    The proportion of scheduled visits that were completed during the 0-12 month period

  5. 6-month Appointment Attendance

    Time frame: 6 months

    The proportion of scheduled visits that were completed during the 0-6 month period

  6. 12-month Mortality

    Time frame: 12 months

    The cumulative incidence of mortality at 12 months after study enrollment

  7. 6-month Predictive value positive (PVP) of machine learning algorithm

    Time frame: 6 months

    Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 6 months

  8. 12-month Predictive value positive (PVP) of machine learning algorithm

    Time frame: 12 months

    Predictive value positive (PVP) of the machine learning algorithm in identifying PLHIV at-risk of disengagement from HIV care within 12 months

  9. 6-month PVP of routine clinical criteria

    Time frame: 6 months

    PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 6 months

  10. 12-month PVP of routine clinical criteria

    Time frame: 12 months

    PVP of the routine clinical criteria (i.e. recent missed visit or detectable viral load, >1000 copies/ml) for identifying PLHIV at-risk of disengagement from HIV care within 12 months

  11. 6-month Predictive value negative (PVN) of the machine learning algorithm

    Time frame: 6 months

    Predictive value negative (PVN) of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 6 months

  12. 12-month PVN of the machine learning algorithm

    Time frame: 12 months

    PVN of the machine learning algorithm in identifying PLHIV not at-risk of disengagement from HIV care within 12 months

  13. 6-month PVN of routine clinical criteria

    Time frame: 6 months

    PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 6 months

  14. 12-month PVN of routine clinical criteria

    Time frame: 12 months

    PVN of the routine clinical criteria for identifying PLHIV not at-risk of disengagement from HIV care within 12 months

  15. Enhanced Adherence Counseling Session Attendance

    Time frame: 6 months

    Proportion of enhanced adherence counseling sessions completed among sessions scheduled

  16. Viral Suppression with enhanced adherence counseling completion

    Time frame: 6 months

    Proportion with HIV viral suppression after completion of enhanced adherence counseling sessions

  17. 6-Month Viral Suppression (<1000 copies/ml)

    Time frame: 6 months

    The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <1000 copies/ml) at 6 months after study enrollment.

  18. 6-Month Viral Suppression (<50 copies/ml)

    Time frame: 6 months

    The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 6 months after study enrollment.

  19. 12-Month Viral Suppression (<50 copies/ml)

    Time frame: 12 months

    The proportion of people living with HIV (PLHIV) and on ART with suppressed HIV viral load ( <50 copies/ml) at 12 months after study enrollment.

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Collaborators

  • Health for a Prosperous Nation
  • Management and Development for Health
  • Ministry of Health, Tanzania
  • National Institute of Mental Health (NIMH)
  • Rasello

Registry information

Official study title

Strengthening the Continuity of HIV Care in Tanzania With Economic Support: Phase II

Acronym: RKPK: Phase II

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 13, 2022
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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